Impact Of Data Integrit on Pharmaceutical Industry ALCOA, ALCOA+, ALCOA++

As well as being crucial for compliance reasons, ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices). Their relevance is also growing as manufacturers in the life sciences sector continue to implement Industry solutions and processes. changed, duplicated, or moved. In terms of data integrity, data refers to all original records, including source data and metadata, whether they are kept on paper or electronically. ALCOA was suggested by various regulatory organisations, including the USFDA, Health Canada, and EMEA, to ensure the integrity of the data Attributable, Legible, Contemporaneous, Original and Accurate.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-05-05
DOI
https://doi.org/10.5281/zenodo.15344828
Primary Topic
Pharmaceutical industry and healthcare
Type
article
Field-Weighted Citation Impact
0.00
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article

Impact Of Data Integrit on Pharmaceutical Industry ALCOA, ALCOA+, ALCOA++

Zenodo (CERN European Organization for Nuclear Research)
Pharmaceutical industry and healthcare
article

Impact Of Data Integrit on Pharmaceutical Industry ALCOA, ALCOA+, ALCOA++

article en

Abstract

As well as being crucial for compliance reasons, ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices). Their relevance is also growing as manufacturers in the life sciences sector continue to implement Industry solutions and processes. changed, duplicated, or moved. In terms of data integrity, data refers to all original records, including source data and metadata, whether they are kept on paper or electronically. ALCOA was suggested by various regulatory organisations, including the USFDA, Health Canada, and EMEA, to ensure the integrity of the data Attributable, Legible, Contemporaneous, Original and Accurate.

Zenodo (CERN European Organization for Nuclear Research)
Industry, innovation and infrastructure
Openalex Percentile: Top 46%
Pharmaceutical industry and healthcare
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Impact Of Data Integrit on Pharmaceutical Industry ALCOA, ALCOA+, ALCOA++ · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS